Physical InactivityT-VIDA-2NCT07421999
Tele-video to Improve Daily Activity 2.0
A study testing A remote social network-based occupational therapy intervention to address physical function, activity and pain in affordable senior housing. in people with Physical Inactivity, run by University of Michigan at 1 site in United States.
Trial summary
In this Phase 1 pilot study, the investigators will test the feasibility of pairing a social network-based approach with a 6-week Occupational Therapist (OT)-led intervention administered remotely to increase physical function and activity among residents of a HUD subsidized independent-living senior housing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- A remote social network-based occupational therapy intervention to address physical function, activity and pain in affordable senior housing.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2026to 28 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- resident of proposed intervention community (HUD subsidized independent-living senior housing community);
- English-proficient;
- ambulatory with or without assistive device (e.g., cane, walker)
Who cannot join
- requiring use of a wheelchair for ambulation;
- requiring highly specialized equipment (e.g., spinal cord injury, leg amputation, wound vacuum assisted closure, heavy leg boot);
- hospitalized within last 3 months;
- has probable dementia (TICSm score <27);
- requiring ongoing complicated treatments (e.g., home oxygen use >2 liters);
- has an active and untreated mental health condition; and
- meets CDC recommendations for physical activity (150+ minutes of moderate-intensity aerobic activity during typical week).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Remote Social Network-Based Occupational Therapy Intervention to Address Physical Function, Activity and Pain in Affordable Senior Housing
In this Phase 1 pilot study, the investigators will test the feasibility of pairing a social network-based approach with a 6-week Occupational Therapist (OT)-led intervention administered remotely to increase physical function and activity among residents of a HUD subsidized independent-living senior housing community. The social network-based approach will involve systematic identification and involvement of influential human agents of change in the community (i.e., the most respected resident and resident with whom others have the most contact) to help recruit and sustain others' participation in the OT intervention. The OT intervention will be comprised of a combination of adapted components from multiple evidence-based interventions including individual meetings with an OT and OT-led group sessions. The goal of the intervention is to increase physical function and activity among older adults through development of habits and skills that address barriers such as pain.
- Conditions
- Physical Inactivity
- Being tested
- A remote social network-based occupational therapy intervention to address physical function, activity and pain in affordable senior housing.
- Keywords
- physical activity, physical function
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A remote social network-based occupational therapy intervention to address physical function, activity and pain in affordable senior housing.Behavioural
In this Phase 1 pilot study, the investigators will test the feasibility of pairing a social network-based approach with a 6-week Occupational Therapist (OT)-led intervention administered remotely to increase physical function and activity among residents of a HUD subsidized independent-living senior housing community. The social network-based approach will involve systematic identification and involvement of influential human agents of change in the community (i.e., the most respected resident and resident with whom others have the most contact) to help recruit and sustain others' participation in the OT intervention. The OT intervention will be comprised of a combination of adapted components from multiple evidence-based interventions including individual meetings with an OT and OT-led group sessions. The goal of the intervention is to increase physical function and activity among older adults through development of habits and skills that address barriers such as pain.
| Study group | Role | What they receive |
|---|---|---|
| Occupational therapy intervention group | Experimental | Not described Receives: Behavioral: A remote social network-based occupational therapy intervention to address physical function, activity and pain in affordable senior housing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Process Outcome - Advisory Committee Members Accept Invitation
Number of originally identified potential Advisory Committee Members who accept the invitation to serve on the committee. Possible scores range from 0 to 2.
Measured: 1 week pre-intervention
Process Outcome - Advisory Committee Member Participation
Number of committee meetings attended by Advisory Committee Members. Possible scores range from 0 to 3.
Measured: Week 5 of intervention
Process Outcome - Individual Activity Participation
Number of individual (one-on-one) intervention activities attended by participants. Possible scores range from 0 to 6.
Measured: Immediately after the intervention, 6 weeks after the intervention started
Process Outcome - Group Activity Participation
Number of group intervention activities attended by participants. Possible scores range from 0 to 4.
Measured: Immediately after the intervention, 6 weeks after the intervention started
Process Outcome - Total Activity Participation
Total number of intervention activities attended by participants (individual and group). Possible scores range from 0 to 10.
Measured: Immediately after the intervention, 6 weeks after the intervention started
Process Outcome - Number Activities Via Zoom
Number of activities attended via zoom as opposed to calling in by telephone. Possible scores range from 0 to 10.
Measured: Immediately after the intervention, 6 weeks after the intervention started
Secondary outcomes (10)
Change in Self-reported Physical Activity
Modified Community Health Activities Model Program questionnaire. This includes 16 questions/items that measure the number of times and the frequency of each activity engaged in during a typical week in the past month. The response scale for each of the 16 items ranges from 1=less than 1 hour to 6=9 or more hours. On this scale, higher values represent a better outcome. A total self-reported physical activity score is calculated by averaging the score of all 16 items. The range for the total score also ranges from 1 to 6. Change will be measured by creating a difference score between the pre and post intervention total scores. Positive change scores represent a better outcome, i.e., an increase in self-reported physical activity.
Measured: 1 week pre and 1 week post the 6-week intervention
Change in Perceived Barriers to Physical Activity
This includes 17 questions/items that measure the degree to which specific things make it more difficult for participants to engage in 30 minutes of moderate intensity physical activity on 5 or more days a week. The response scale for each of the 17 items ranges from 1=not at all more difficult to 4=much more difficult. On this scale, lower values represent a better outcome. A total perceived barriers to physical activity score is calculated by averaging the score of all 17 items. The range for the total score also ranges from 1 to 4. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in perceived barriers to physical activity.
Measured: 1 week pre and 1 week post the 6-week intervention
Change in Pain Interference
This includes 8 questions/items that measure how much pain interferes with daily activities. The response scale for each the 8 items ranges from 1=not at all to 5=very much. On this scale, lower values represent a better outcome. A total pain interference score is calculated by averaging the score of all 8 items. The range for the total score also ranges from 1 to 5. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in pain interference.
Measured: 1 week pre and 1 week post the 6-week intervention
Change in Pain Intensity
This includes one question about how participants rate their pain on average using a scale ranging from 0=no pain to 10=the worst imaginable pain. Change will be measured by creating a difference score between the pre and post intervention scores.
Measured: 1 week pre and 1 week post the 6-week intervention
Change in Physical Function Difficulty
This includes a modified version of the National Health and Aging Trends Study disability and functioning measure. The measure includes 11 questions/items assessing difficulty performing self-care, mobility, and household activities. The response scale for each of the 11 items asking about difficulty doing these activities ranges from 1=none to 4=a lot. On this scale, lower values represent a better outcome. A total physical function difficulty score is calculated by averaging the score of all 11 items. The range for the total score also ranges from 1 to 4. Change will be measured by creating a difference score between the pre and post intervention total scores. Negative change scores represent a better outcome, i.e., a decrease in physical function difficulty.
Measured: 1 week pre and 1 week post the 6-week intervention
Change in Self-efficacy in Activity
This includes 10 questions/items that measure participants' confidence in doing a number of activities that will be discussed during the intervention. The response scale for each of the 10 items ranges from 1=not confident at all to 5=completely confident. On this scale, higher values represent a better outcome. A total self-efficacy in activity score is calculated by averaging the score of all 10 items. The range for the total score also ranges from 1 to 5. Change will be measured by creating a difference score between the pre and post intervention total scores. Positive change scores represent a better outcome, i.e., an increase in self-efficacy in activity.
Measured: 1 week pre and 1 week post the 6-week intervention
Change in Percentage of Other Participants Known
This will include a measure of the percentage of other participants each participant reports knowing. Possible scores range from 0 to 100. Change will be measured by creating a difference score between the pre and post intervention scores.
Measured: 1 week pre and 1 week post the 6-week intervention
Change in Respect Level of Other Participants
This will include a measure of how much respect on average participants have for the other participants that they report knowing. This question will be asked on a scale ranging from 1=respect them very much to 5=don't respect them at all. Change will be measured by creating a difference score between the pre and post intervention scores.
Measured: 1 week pre and 1 week post the 6-week intervention
Change in Sedentary Behavior
Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average amount of time that participants were sedentary per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores.
Measured: 1 week pre and 1 week post the 6-week intervention
Change in Number of Steps
Participants will be asked to wear an accelerometer for 7 days following participation in pre- and post intervention interviews. Data from the accelerometers will be used to quantify the average number of steps taken per day over the 7 days. Change will be measured by creating a difference score between the pre and post intervention scores.
Measured: 1 week pre and 1 week post the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start20 Mar 2026
- Primary completion28 May 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical InactivityStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Noah J Webster, University of Michigan
- Investigators
- Noah J Webster, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421999
- Sponsor's protocol ID
- HUM00238400
- Other IDs
- P30AG022845
- Acronym
- T-VIDA-2
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Remote Social Network-Based Occupational Therapy Intervention to Address Physical Function, Activity and Pain in Affordable Senior Housing
- ClinicalTrials.gov ID
- NCT07421999
- Acronym / sponsor ID
- T-VIDA-2 / HUM00238400
- Conditions
- Physical Inactivity
- Keywords
- physical activity, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Cornell University, National Institute on Aging (NIA)
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 28 May 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this Phase 1 pilot study, the investigators will test the feasibility of pairing a social network-based approach with a 6-week Occupational Therapist (OT)-led intervention administered remotely to increase physical function and activity among residents of a HUD subsidized independent-living senior housing community. The social network-based approach will involve systematic identification and involvement of influential human agents of change in the community (i.e., the most respected resident and resident with whom others have the most contact) to help recruit and sustain others' participation in the OT intervention. The OT intervention will be comprised of a combination of adapted components from multiple evidence-based interventions including individual meetings with an OT and OT-led group sessions. The goal of the intervention is to increase physical function and activity among older adults through development of habits and skills that address barriers such as pain.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Occupational therapy intervention group | Experimental | Behavioral: A remote social network-based occupational therapy intervention to address physical function, activity and pain in affordable senior housing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- resident of proposed intervention community (HUD subsidized independent-living senior housing community);
- English-proficient;
- ambulatory with or without assistive device (e.g., cane, walker)
Key exclusion criteria (7 listed)
- requiring use of a wheelchair for ambulation;
- requiring highly specialized equipment (e.g., spinal cord injury, leg amputation, wound vacuum assisted closure, heavy leg boot);
- hospitalized within last 3 months;
- has probable dementia (TICSm score <27);
- requiring ongoing complicated treatments (e.g., home oxygen use >2 liters);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A remote social network-based occupational therapy intervention to address physical function, activity and pain in affordable senior housing.In this Phase 1 pilot study, the investigators will test the feasibility of pairing a social network-based approach with a 6-week Occupational Therapist (OT)-led intervention administered remotely to increase physical function and activity among residents of a HUD subsidized independent-living senior housing community. The social network-based approach will involve systematic identification and involvement of influential human agents of change in the community (i.e., the most respected resident and resident with whom others have the most contact) to help recruit and sustain others' participation in the OT intervention. The OT intervention will be comprised of a combination of adapted components from multiple evidence-based interventions including individual meetings with an OT and OT-led group sessions. The goal of the intervention is to increase physical function and activity among older adults through development of habits and skills that address barriers such as pain. | Behavioural | Occupational therapy intervention group |
Primary outcome
Process Outcome - Advisory Committee Members Accept Invitation
Time frame: 1 week pre-intervention
Number of originally identified potential Advisory Committee Members who accept the invitation to serve on the committee. Possible scores range from 0 to 2.
Process Outcome - Advisory Committee Member Participation
Time frame: Week 5 of intervention
Number of committee meetings attended by Advisory Committee Members. Possible scores range from 0 to 3.
Process Outcome - Individual Activity Participation
Time frame: Immediately after the intervention, 6 weeks after the intervention started
Number of individual (one-on-one) intervention activities attended by participants. Possible scores range from 0 to 6.
Process Outcome - Group Activity Participation
Time frame: Immediately after the intervention, 6 weeks after the intervention started
Number of group intervention activities attended by participants. Possible scores range from 0 to 4.
Process Outcome - Total Activity Participation
Time frame: Immediately after the intervention, 6 weeks after the intervention started
Total number of intervention activities attended by participants (individual and group). Possible scores range from 0 to 10.
Process Outcome - Number Activities Via Zoom
Time frame: Immediately after the intervention, 6 weeks after the intervention started
Number of activities attended via zoom as opposed to calling in by telephone. Possible scores range from 0 to 10.
10 secondary outcomes
Change in Self-reported Physical Activity
Time frame: 1 week pre and 1 week post the 6-week intervention
Change in Perceived Barriers to Physical Activity
Time frame: 1 week pre and 1 week post the 6-week intervention
Change in Pain Interference
Time frame: 1 week pre and 1 week post the 6-week intervention
Change in Pain Intensity
Time frame: 1 week pre and 1 week post the 6-week intervention
Change in Physical Function Difficulty
Time frame: 1 week pre and 1 week post the 6-week intervention
Change in Self-efficacy in Activity
Time frame: 1 week pre and 1 week post the 6-week intervention
Change in Percentage of Other Participants Known
Time frame: 1 week pre and 1 week post the 6-week intervention
Change in Respect Level of Other Participants
Time frame: 1 week pre and 1 week post the 6-week intervention
Change in Sedentary Behavior
Time frame: 1 week pre and 1 week post the 6-week intervention
Change in Number of Steps
Time frame: 1 week pre and 1 week post the 6-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah J Webster, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A remote social network-based occupational therapy intervention to address physical function, activity and pain in affordable senior housing. in people with Physical Inactivity, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Process Outcome - Advisory Committee Members Accept Invitation (time frame: 1 week pre-intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.